87780 Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices 

as possible to process the request. 

Closed captioning and live ASL 

interpreter services will be available. 

Shenaye ́ V. Holmes, 

Senior Advisor, Federal Privacy Council, 

Made in America Council, Chief Acquisition 

Officers Council. 

[FR Doc. 2023–27781 Filed 12–18–23; 8:45 am] 

BILLING CODE 6820–69–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–1716] 

Registration and Listing of Cosmetic 

Product Facilities and Products; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Registration and Listing of Cosmetic 

Product Facilities and Products.’’ The 

guidance will assist persons submitting 

cosmetic product facility registrations 

and product listing submissions to FDA 

under the Modernization of Cosmetics 

Regulation Act of 2022 (MoCRA). This 

guidance also includes a new draft 

section, Appendix B, for comment 

purposes only, that describes frequently 

asked questions and answers about 

cosmetic product facility registrations 

and product listing submissions. Aside 

from that section, this guidance finalizes 

the draft guidance that was published 

on August 8, 2023. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 19, 2023. 

However, the portion of this guidance 

that describes frequently asked 

questions and answers, is being 

distributed for comment purposes only. 

To ensure that the Agency considers 

your comment on this draft section 

before it begins work on the final 

version of this section of the guidance, 

submit either electronic or written 

comments on this section by January 18, 

2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https:// 

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–1716 for ‘‘Registration and 

Listing of Cosmetic Product Facilities 

and Products.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https:// 

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to Office of 

Cosmetics and Colors, Center for Food 

Safety and Applied Nutrition, Food and 

Drug Administration, 5001 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Ross, Office of the Chief 

Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4332, Silver Spring, 

MD 20993–0002, 301–796–4880 (this is 

not a toll-free number), email: 

QuestionsAboutMoCRA@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled 

‘‘Registration and Listing of Cosmetic 

Product Facilities and Products.’’ We 

are issuing this guidance consistent 

with our good guidance practices 

regulation (21 CFR 10.115). The 

guidance represents the current thinking 

of FDA on this topic. It does not 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 242 / Tuesday, December 19, 2023 / Notices 87781 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

On December 29, 2022, the President 

signed the Consolidated Appropriations 

Act, 2023 (Pub. L. 117–328) into law, 

which included MoCRA. Among other 

provisions, MoCRA added section 607 

to the Federal Food, Drug, and Cosmetic 

Act (FD&C Act), establishing 

requirements for cosmetic product 

facility registration and cosmetic 

product listing. Section 607(a) of the 

FD&C Act (21 U.S.C. 364c(a)) requires 

every person that owns or operates a 

facility that engages in the 

manufacturing or processing of a 

cosmetic product for distribution in the 

United States to register each facility 

with FDA no later than 1 year after the 

date of enactment. In addition to the 

registration requirements, section 607(c) 

of the FD&C Act requires that for each 

cosmetic product, the responsible 

person submit to FDA ‘‘a cosmetic 

product listing.’’ Certain small 

businesses, as defined in section 612 of 

the FD&C Act (21 U.S.C. 364h), are 

exempt from the registration and listing 

requirements. 

In the Federal Register of August 8, 

2023 (88 FR 53490), we made available 

a draft guidance for industry entitled 

‘‘Registration and Listing of Cosmetic 

Product Facilities and Products’’ and 

gave interested parties an opportunity to 

submit comments by September 7, 2023, 

for us to consider before beginning work 

on the final version of the guidance. We 

received numerous comments on the 

draft guidance and have modified the 

final guidance where appropriate. 

Changes to the guidance include 

additional information on the facility 

registration number, United States 

agent, electronic and paper submission, 

as well as incorporating FDA’s 

compliance policy we made available in 

a guidance for industry as described in 

the Federal Register of November 8, 

2023 (88 FR 77323). In addition, we 

made editorial changes to improve 

clarity. New appendix B of this 

guidance is highlighted in grey, 

describes frequently asked questions 

and answers, and is marked ‘‘for 

comment purposes only’’ to provide an 

opportunity for comment before it is 

finalized. Aside from appendix B, this 

guidance finalizes the draft guidance 

that was published on August 8, 2023. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in section 607 of the FD&C 

Act have been approved under 0910– 

0599. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/CosmeticGuidances, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// 

www.regulations.gov. Use the FDA 

websites listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: December 12, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27649 Filed 12–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–P–4596] 

Determination That MEPHYTON 

(Phytonadione) Tablets, 5 Milligrams, 

Were Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that MEPHYTON 

(phytonadione) tablets, 5 milligrams 

(mg), were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination means that FDA will not 

begin procedures to withdraw approval 

of abbreviated new drug applications 

(ANDAs) that refer to this drug product, 

and it will allow FDA to continue to 

approve ANDAs that refer to the 

product as long as they meet relevant 

legal and regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

MEPHYTON (phytonadione) tablets, 5 

mg, are the subject of NDA 010104, held 

by Bausch Health Americas, Inc., and 

initially approved in 1955. MEPHYTON 

is a vitamin K replacement indicated for 

the treatment of adults with the 

following coagulation disorders, which 

are due to faulty formation of factors II, 

VII, IX and X when caused by vitamin 

K deficiency or interference with 

vitamin K activity: 

• Anticoagulant-induced prothrombin 

deficiency caused by coumarin or 

indanedione derivatives 

• Hypoprothrombinemia secondary to 

antibacterial therapy 

• Hypoprothrombinemia secondary to 

factors limiting absorption or 

synthesis of vitamin K, e.g., 

obstructive jaundice, biliary fistula, 

sprue, ulcerative colitis, celiac 

disease, intestinal resection, cystic 

fibrosis of the pancreas, and regional 

enteritis 

• Other drug-induced 

hypoprothrombinemia where it is 


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